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A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine

NCT06848075 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2025-09-03

No results posted yet for this study

Summary

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep as compared to placebo in the treatment of moderate or severe migraine.

Conditions

  • Acute Migraine

Interventions

DRUG

Elismetrep (K-304) Dose Level 1

Administered orally

DRUG

Elismetrep (K-304) Dose level 2

Administered orally

DRUG

Elismetrep (K-304) Dose level 3

Administered orally

DRUG

Elismetrep (K-304) Dose level 4

Administered orally

DRUG

Placebo

Administered orally

Sponsors & Collaborators

  • Kallyope Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-05
Primary Completion
2025-08-11
Completion
2025-08-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06848075 on ClinicalTrials.gov